Adults 18 to 65, any sex, with Dermatitis, Atopic or Dermatitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Allergen-induced Eosinophils in the SkinPrimary· Day 65, 24 hours post-intradermal allergen challenge
The primary objective is to evaluate the effect of benralizumab on the allergen-induced number of eosinophils in the skin assessed by histological examination compared to placebo. Intradermal saline challenge will be used as a control.
Group
Value
95% CI
Benralizumab
11.95
± 28.51
Placebo Control
71.15
± 130.1
Allergen-induced Late Phase Cutaneous ResponseSecondary· Day 65, at 24 hours post-intradermal allergen challenge
To evaluate the effect of Benralizumab on the allergen-induced late phase cutaneous response by measuring the skin wheal compared to placebo.
Group
Value
95% CI
Benralizumab
18.89
± 6.33
Placebo Control
26.57
± 12.07
Sponsor's own description
Atopic Dermatitis (AD), also known as eczema, is a common skin disease characterized by itchy lesions. The prevalence of AD has increased over the past few decades, with 15-30% of children and 2-10%of adults being affected. The lesions of AD patients are very inflamed, with an increased number of inflammatory cells in the skin. There are not many medications available that are fully effective and can be used long-term for treatment of atopic dermatitis. Benralizumab is a monoclonal antibody used for treatment of a type of asthma called "eosinophilic asthma". Atopic dermatitis is also associated with elevated levels of eosinophils, and we would like to determine if benralizumab is effective in patients with atopic dermatitis. This is a randomized, double-blind, parallel group, placebo-controlled study will evaluate the effect of 3 doses of a fixed 30 mg dose of benralizumab administered subcutaneously (SC) every 4 weeks to patients with moderate-to-severe atopic dermatitis, on the severity of atopic dermatitis, and the cellular inflammation of skin lesions in these patients. Anti-inflammatory properties of benralizumab when a skin flare is induced in a controlled laboratory setting, in addition to the effects of benralizumab on skin that is already inflamed will be examined.It is hypothesized that benralizumab will attenuate eosinophilic inflammation in the skin.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07444567 — Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit Fr
· Phase 3
· not yet recruiting
NCT06512883 — A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
· Phase 3
· recruiting
NCT06465485 — STEP: Phase IIIb Study of Benralizumab to Step-down Maintenance Therapy in Patients With Severe Eosinophilic Asthma
· Phase 3
· active not recruiting
NCT06385236 — Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping
· Phase 4
· recruiting
NCT05966584 — A Study to Prevent Rash in People Starting Alpelisib for the Treatment of Breast Cancer
· Phase 2
· terminated
Other recruiting trials for Dermatitis, Atopic
Currently open trials in the same condition.
NCT07230860 — A Study of JNJ-95597528 in Participants With Moderate to Severe Atopic Dermatitis
· Phase 2
· recruiting
NCT06899204 — Real World Efficiency of Abrocitinib Treatment at Patients With Moderate to Severe Atopic Dermatitis Who Had Inadequate
· recruiting
NCT07042126 — Evaluation of 611 in Chinese Adolescents With Moderate to Severe Atopic Dermatitis
· Phase 3
· recruiting
NCT06881251 — A Study of JNJ-95475939 in the Treatment of Participants With Moderate to Severe Atopic Dermatitis (AD)
· Phase 2
· active not recruiting
NCT06554847 — Evaluation of 611 in Combination With Topical Corticosteroid in Participants With Moderate to Severe Atopic Dermatitis
· Phase 3
· active not recruiting
Other McMaster University trials
Trials by the same sponsor.
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· NA
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NCT07486505 — Mindfulness in Fracture Recovery and Reduction of Opioid Reliance: Evaluating the Feasibility of Implementing a Brief, M
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by McMaster University
Last refreshed: 22 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03563066.